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Cerebral Autoregulation and Delirium Study

Reducing Delirium After Cardiac Surgery: Personalized Targeted Blood Pressure Management Strategy Using Cerebral Autoregulation Monitoring: A Pilot Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07671404
Acronym
AUTO-POD
Enrollment
60
Registered
2026-06-26
Start date
2026-06-01
Completion date
2028-06-30
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Delirium - Postoperative

Keywords

Cerebral Autoregulation Monitoring

Brief summary

Approximately one in four elderly patients develops postoperative delirium (POD) after cardiac surgery. POD is associated with prolonged hospitalization, increased mortality, and higher health care costs. While patient-related risk factors are often difficult to modify, surgery- and anesthesia-related factors may be optimized to reduce the incidence of POD. One potentially modifiable factor is intraoperative blood pressure management. Current practice commonly relies on standardized blood pressure targets during cardiac surgery; however, this "one-size-fits-all" approach may not account for individual variability in cerebral perfusion requirements. This study proposes a personalized blood pressure management strategy based on real-time monitoring of cerebral autoregulation, with the goal of maintaining optimal cerebral perfusion and protecting the brain from both hypo- and hyper-perfusion

Detailed description

The primary aim of this pilot study is to evaluate the feasibility of conducting a subsequent definitive trial by assessing recruitment rates, protocol adherence, and the completeness and quality of short-term outcome data collection. The pilot study will also provide an opportunity to identify potential challenges and optimize the design of the larger trial, if necessary. If the study hypothesis is confirmed and subsequently reproduced in larger, rigorous clinical trials, the findings could have important implications for intraoperative blood pressure management in elderly patients undergoing cardiac surgery. Specifically, this research may support a transition from the current "one-size-fits-all" blood pressure management strategy toward an individualized, real-time approach guided by cerebral autoregulation monitoring. Such a personalized strategy could potentially reduce the incidence of postoperative delirium (POD) in this high-risk population. Conversely, premature implementation of personalized blood pressure management based solely on the currently available preliminary evidence may lead to unintended adverse consequences. Therefore, the proposed pilot study is essential to provide critical feasibility and safety data before proceeding to a larger definitive trial. This study will be conducted as a prospective, single-centre, randomized controlled clinical trial comparing a real-time cerebral autoregulation monitoring-based blood pressure management strategy with standard care. Participants will be randomized into two groups: Intervention Group: Blood pressure management guided by real-time cerebral autoregulation monitoring. Control Group: Standard intraoperative blood pressure management according to current institutional practice.

Interventions

DEVICEMespere NeuroOs (Mespere Life Sciences) monitor

bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area on the fronto-temporal area of all patients.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Intervention group or the control group (1:1 ratio). Prior to anesthesia induction, bilateral Mespere NeuroOs cerebral oximeter sensors will be placed on the fronto-temporal area of all patients. In the intervention group, cerebral autoregulation will be monitored intra-operatively for the duration of surgery. In the control group, the cerebral oximetry monitor will be electronically blinded, but data will be continuously recorded and stored for later analysis.

Intervention model description

This will be a prospective, single-centre, randomized, controlled clinical trial comparing real-time cerebral autoregulation monitoring- based blood pressure management strategy to standard care. 2 Groups: Intervention and Control

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Consenting patients aged ≥ 60 years undergoing elective complex cardiac surgery (coronary artery bypass grafting plus valve surgery, double-valve surgery, triple-valve surgery, redo operations, or aortic arch surgery), or patients aged ≥ 70 years undergoing isolated coronary artery bypass grafting or single-valve repair/replacement surgery.

Exclusion criteria

* Patients with symptomatic cerebrovascular disease. * History of delirium. * Major neurocognitive impairment (e.g., dementia or Mini-Mental State Examination score \< 10). * Schizophrenia.

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rate2 year1\. Recruitment rate: Percentage of eligible patients enrolled in the study (feasibility target: \>10%).
Non-adherence with the protocol2 yearNon-adherence with the protocol (percentage of patients with VRx \> 0.3 where no intervention was performed; \<10%)
Completeness and quality of POD assessment2 yearCompleteness and quality of POD assessment (percent of patients for whom all CAM-ICU assessments are complete and conclusive; \> 90%)

Secondary

MeasureTime frameDescription
Overall incidence of impaired cerebral autoregulation2 yearOverall incidence of impaired cerebral autoregulation in the intervention and control groups.
Percentage of patients in whom attempted restoration2 yearPercentage of patients in whom attempted restoration of VRx to autoregulation range was unsuccessful
The number of interventions required2 yearThe number of interventions required to restore VRx to autoregulation range

Contacts

CONTACTGeorge Djaiani, MD FRCAFRCPS
george.djaiani@uhn.ca416-340-4800
CONTACTDeep Grewal
deep.grewal@uhn.ca416-340-4800
PRINCIPAL_INVESTIGATORGeorge Djaiani

Toronto General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026